MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIFE2000; CONTINUOUS, VENTILATOR, HOME USE

Model Number	BT-20-0002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient developed a sinus infection in conjunction with a life200 device.The nurse practitioner made a home visit and prescribed a course of unspecified antibiotics.After an unspecified amount of time, the infection did not clear up.Another course of antibiotics was added with augmentin.Reportedly, ¿several coursed of antibiotics¿ were required to ¿clear the infection.¿ there was no report of a device malfunction.Patient uses ¿two vents and two compressors.¿ furthermore, the patient was asked if they were able to complete the recommended supply maintenance of nasal interface/combo tubing, and the patient stated that ¿due to trainers¿ distance from them, and the inconsistency of training schedules, they did not replace the device supplies per maintenance¿.Patient stated they were ¿washing the interface¿.The patient decided to return the devices as they decided to discontinue its use.No further information was available at the time of this report.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h11.H11: the device was returned for evaluation.The device underwent functional testing, including the 500ml testing and the device manifold malfunctioned causing low output.The event history log was reviewed and found multiple instances of low pip alarms.A service history review revealed no indication that the parts replaced during servicing in 07/2024 caused or contributed to the reported event.The reported condition was verified.End of line testing failed due to low volume output at 500ml, resulting in the device not meeting specification.The cause was determined to be a malfunctioning manifold.The device was scrapped.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIFE2000
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM ST. PAUL; 1020 west county road f; st. paul MN 55126
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22323287
• Report Number: 2183816-2025-00035
• Device Sequence Number: 21031155
• Product Code: NOU
• UDI-Device Identifier: 00887761978201
• UDI-Public: (01)00887761978201
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: BT-20-0002
• Device Catalogue Number: BT-20-0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPRESSOR.; VENTILATOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female